ABSTRACT
Background: Molecular tissue testing in non?small cell lung cancer (NSCLC) is done for the assessment of epidermal growth factor receptor (EGFR) mutation. EGFR mutation status is the basis for deciding the targeted treatment option for patients with metastatic NSCLC. The nonavailability of tissue samples and contraindications for biopsy pose a significant challenge. Hence circulating tumor DNA (ctDNA) by liquid biopsy can be a viable alternative for NSCLC patients. Methods: This study was conducted at 15 sites across India. EGFR mutation testing from plasma was done as part of the study at the central laboratory by the next?generation sequencing (NGS) method and EGFR mutation test results from tissue samples (done as part of routine practice) were recorded for all the patients. Results: Out of the total patients enrolled (N = 245) the majority (64.5% n = 158) were men. The median age of patients was 58.0 (range: 26�) years. The concordance between plasma and tissue testing was found to be 82.9% (95% confidence interval [CI]: 77.55 87.45). The sensitivity and specificity of NGS were 68.4% (95% CI: 56.92 78.37) and 90.1% [95% CI: 84.36 94.21) respectively. Plasma testing detected 1.2% (n = 3) and tissue sample testing detected 2.4% (n = 6) positive status of exon 20 T790M EGFR mutation. Out of the total number of patients enrolled 25 were tissue positive and plasma negative while 16 were plasma positive and tissue negative. Conclusions: This real?world study in Indian patients suggests that plasma testing for EGFR mutation analysis is a viable diagnostic option in newly diagnosed advanced/metastatic NSCLC patients. The noninvasive plasma procedure in patients without available/evaluable tumor sample may enable more patients to receive appropriate targeted therapies by providing clinicians with valuable insights into the patient抯 tumor mutation status. ClinicalTrials.gov Identifier: NCT03562819
ABSTRACT
Context: Health-related quality of life (HRQOL) assessment plays an important role in the decision-making process in oncology. Aims: The aim of the study was to translate European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) OES18 and OG25 in Punjabi language for HRQOL assessment of patients diagnosed with esophagus and esophagogastric malignancies. Subjects and Methods: The EORTC translation guidelines were duly followed to translate QLQ-OES18 and OG25 into Punjabi language. Each set of questionnaire was independently translated by two forward translators, followed by backward translation of the reconciled version by two independent translators. The final version was submitted to the EORTC Translation Team and served to the patients for the pilot testing. Results: The questionnaire was administered to ten patients each of esophagus and esophagogastric malignancies who were evaluated and treated at our hospital. Every patient underwent an interview to check if any of the questions was difficult, uncomfortable, or upsetting to answer. Their concerns were recorded as per the template provided by the EORTC team and due changes done if required. Conclusions: The EORTC QLQ-OES18 and OG25 questionnaire has been translated to Punjabi language and subsequently approved for usage.
ABSTRACT
Context: The fluctuations of proteins in multiple myeloma (MM) are well-known markers for checking the status of the patients. Aims: The objective of this study was to examine three proteins that have an important role in disease progression. Subjects and Methods: The study was performed with two groups: 30 MM stage I patients' (14 females/16 males; aged 60.83 ± 12.38 years) as case group and 40 healthy individuals (18 females/22 males; aged 57.65 ± 6.43 years) as control group. Both groups have been matched in gender and age. Bone sialoprotein (BSP), osteopontin (OPN), and β2-microglobulin (β2M) were measured with an enzyme-linked immunosorbent assay. Results: Serum BSP levels of MM-I patients was significantly higher than that of healthy controls (29.24 ± 5.57 vs. 20.89 ± 3.67, P = 0.001). OPN levels of MM-I patients were significantly lower than that of healthy individuals (12.03 ± 3.45 vs. 19.35 ± 4.67, P = 0.001). β2M levels of patients and controls were similar (1.49 ± 0.67 vs. 1.29 ± 0.55, P = 0.193). Conclusions: The results suggested that myeloma cells may affect the production of BSP and OPN, which possibly contributes to osteoclastic bone resorption in MM-I patients. Their levels may be a useful biomarker for assessing bone destruction in MM-I patients and distinguishing MM-I from healthy individuals